Artificial Intelligence


On 2nd February EU Member states voted unanimously to adopt the text of the proposed AI Act. There are still some additional steps to be completed before the EU AI Act can become law, including votes by The European Parliament’s Internal Market and Civil Liberties Committees on 13th February, followed by a plenary vote scheduled for 10-11 April. However, further significant opposition is no longer expected. Please see proposed text of Regulation


The UK government published its response to the AI regulation White Paper on 6th February, emphasising a pro-innovation, sector-based approach to AI regulation. See Response here

Clinical Trials


EMA has highlighted there is one year left (31 January 2025) for the transition of all ongoing clinical trials in the EU to be transitioned to the Clinical Trials Information System (CTIS) – See EMA press release with further information and guidance

Competition Law


The Competition and Markets Authority (CMA) has launched an investigation into Vifor Pharma (Vifor), a global pharmaceutical company, over its suspected anti-competitive conduct in the supply of intravenous (IV) iron deficiency treatments for National Health Service (NHS) patients in the UK. See press release

Marketing Authorisations


EMA February issue of human medicine highlights which contains information on CHMP opinions and new medicine approvals can be accessed here



The US Food and Drug Administration (FDA) has published new guidance on the safe manufacturing of veterinary active pharmaceutical ingredients. The guidance, Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products largely clarifies that human medicine GMP guidelines (ICH Q7) apply to the manufacture of veterinary active pharmaceutical ingredients. It is expected that the guidance will also be implemented in Japan, the EU and the UK.



The European Commission has provided EMA with a grant of ten million euros to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors. See press release

Veterinary Medicines


EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines. See veterinary medicines highlights document

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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